DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER- pyrithione zinc soap

Dermaharmony Pyrithione Zinc by

Drug Labeling and Warnings

Dermaharmony Pyrithione Zinc by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 2%

PURPOSE

Purpose

Dandruff, Seborrheic dermatitis soap

INDICATIONS & USAGE

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

WARNINGS

Warnings

For external use only

Ask a doctor before use if you havea condition that covers a large area of the body.

When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Use on affected areas in place of your regular soap
• For best results use at least twice a week or as directed by a doctor
• Work up a lather using warm water and massage into affected areas
• Rinse well

STORAGE AND HANDLING

Other information

• Store at room temperature
• Lot number and expiration date are printed on back panel.

INACTIVE INGREDIENT

Inactive ingredients

Sodium palmate, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *May contain this ingredient

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

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Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PRINCIPAL DISPLAY PANEL

dermaharmony

2% Pyrithione Zinc SOAP with Shea Butter

For Seborrheic Dermatitis & Dandruff

NET WT 3.7 OZ (105 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY PYRITHIONE ZINC  WITH SHEA BUTTER
pyrithione zinc soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM COCOATE (UNII: R1TQH25F4I)
GLYCERIN (UNII: PDC6A3C0OX)
OATMEAL (UNII: 8PI54V663Y)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM PALMATE (UNII: S0A6004K3Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ROSEMARY (UNII: IJ67X351P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-017-37	105 g in 1 PACKAGE; Type 0: Not a Combination Product	04/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	04/25/2022

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-017)